None listed
Conditions
Brief summary
Ulcerative colitis (UC) is a chronic, disabling immune mediated inflammatory condition affecting the large bowel, which is thought to be caused by an aberrant interaction between the immune system and a dysbiotic intestinal microbiome. There is emerging evidence that faecal microbiota transplantation (FMT) is effective in treating UC. This is a multi-centre double blind, randomised, placebo-controlled trial of orally administered FMT in patients with chronic active UC over an 8 week period.
Interventions
Orally administered encapsulated lyophilised faecal microbiota transplantation administered daily over a period of 8 weeks. Given the nature of FMT, the "dose" of FMT will vary.
-Participants will be contacted weekly to check compliance and for further reminders and arranged unused product return.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Confirmed diagnosis of ulcerative colitis of at least 3 months by standard clinical, endoscopic, and histological criteria -Clinically and endoscopically active ulcerative colitis
Exclusion criteria
-Acute Severe Colitis -Crohn's disease -Proctitis -Pregnancy or breast feeding -Previous FMT treatment -Significant medical comorbidities
Outcome results
None listed